Agitation in Post Operative Neurosurgical Patients

Agitation is a significant clinical issue in anesthesiology and critical care medicine. Several studies have carried out to survey the epidemics of agitation in post-anesthesia care unit and intensive care unit, and results revealed that agitation had an adverse impact on outcomes. To our clinical experience, agitation can occur in postoperative neurosurgical patients, and is often difficult to manage. However, agitation in this subset of patients is poorly evaluated. In present study, adult patients following craniotomy will be enrolled consecutively, and incidence, risk factor and outcome of emergent agitation will be investigated. The results of the study will provide basic data for prevention and treatment of agitation in postoperative neurosurgical patients.

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Key information

Conditions

Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Craniotomy Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jian-Xin Zhou

Beijing, Beijing Municipality, 100050, China

About this study

The study will enroll 120 consecutive adult patients admitted to Neuro-ICU for post-operative care following craniotomy. Sedation-Agitation Scale (SAS) will be evaluated and documented every hour or as needed during stay in ICU by nurse on duty. Emergent agitation is defined as SAS of 5 to 7 at anytime during the first 24 hr of ICU stay.Patients are divided into 2 groups: non-agitation group (SAS 1-4) and agitation group (SAS 5-7).Data collection includes pre-operative records, events during anesthesia and operation, events during ICU stay, and outcomes. The primary outcome is complications such as self-removal of endotracheal tube, central venous or bladder catheters. The secondary and third outcomes are ICU stay and Glasgow Outcome Scale at hospital discharge, respectively. Incidence of agitation will be calculated to present an epidemiological knowledge. Univariate analyses between the two groups will be used for preliminary selection of model variables. Then stepwise block logistic regression will be applied to model the risk of agitation using significant univariate predictors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adult patients admitted to Neuro-ICU for post-operative care following craniotomy

Exclusion criteria

age<18 yr old
time interval between operation to ICU admission is longer than 24 hr
re-operation within 72 hr
persistently comatose during first 24 hr after operation (GCS≤8)

Treatment and study plan

Primary outcomes

Complications: self-removal of endotracheal tube, central venous or bladder catheters.

Time frame: 24 hours

Secondary outcomes

ICU stay and Glasgow Outcome Scale

Time frame: At hospital discharge

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

A Prospective Survey of Emergent Agitation Following Craniotomy: Incidence, Risk Factors and Outcomes

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2013
First posted: Jan 10, 2008
Registry last updated: Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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